Comparison of Intraabdominal Pressure

Prone Position Clinical Trial

— IAP  

Official title:

Comparison of Intraabdominal Pressure and Respiratory Parameter Changes According to Positional Apparatus in the Prone Position

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT02094976
• Other study ID #: IAP_protocol
• Status: Unknown status
• Phase: N/A
• First received: March 20, 2014
• Last updated: March 20, 2014
• Start date: September 2013

Study information

• Verified date: March 2014
• Source: Seoul National University Hospital
• Contact: Hee Pyung Park, MD Phd
• Phone: 82-2-2072-2466
• Email: hppark[@]snu.ac.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Increased intra-abdominal pressure(IAP) might influence on perioperative morbidity related to increased CVP, PVWP, SVR, PAP and decreased venous return and cardiac output. Prone position has been known to increase IAP. In clinical field, various apparatuses has developed to minimize IAP elevation during prone position operation.

In this study, we would compare the changes of IAP and respiratory system compliance according to positional apparatus in prone position.

Description:

In clinical field, Wison frame, chest rolls and Jackson table have been widely used for prone position surgery. Among those apparatus, Jackson table has padded supports under the chest and pelvis, so that the abdomen can hang freely and prevent the abdominal compression. By reducing abdominal and thoracic pressure, Jackson table would reduce blood loss, and less effects on pulmonary mechanics. But few studies has known to compare IAP with other positioning apparatus such as Wilson frame or chest roll.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 138
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

Inclusion Criteria:

• Patients who are scheduled for prone positioned spinal surgery

• ASA Physical Status Classification System class I or II

Exclusion Criteria:

• Patients who did not agree

• BMI > 30kg/m2

• Patients who did not insert urinary foley catheter

• Patients who have COPD or emphysema

• Patients who have severe spine deformities such as scoliosis

Related Conditions & MeSH terms

• Prone Position

Intervention

Device:
• Jackson surgical table
After standard total intravenous anesthesia using propofol and remifentanil continous infusion, patients were turned to the prone position on a Jackson table with two padded supports on each side. The supports were positioned under the lateral chest and at the iliac crest.
• Wilson frame
After standard total intravenous anesthesia using propofol and remifentanil continous infusion, patients were turned to the prone position on a Wilson frame. The supports were positioned vertically from shoulder to iliac crest.
• Chest roll
After standard total intravenous anesthesia using propofol and remifentanil continous infusion, patients were turned to the prone position on a chest roll. The supports were positioned vertically from shoulder to iliac crest.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University of Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Estimated blood loss (EBL)	Compare the EBL among the groups.	intraoperatively
Primary	changes of Intraabdominal presure (IAP)	Compare IAP changes from supine to prone according to the positional apparatus : Wilson frame, Chestrolls and Jackson table	5 minute after position change
Secondary	Changes of IAP and total respiratory system comliance (Crs) accoridng to PEEP change	Compare IAP and Crs according to PEEP changes in each group. PEEP applied 0,3,6 and 9 cm H2O and recoding was done at 1min after PEEP change.; Total respiratory system compliance (Crs) = TV/(Pplat-PEEP)	1min after PEEP change
Secondary	changes of dead space ventilation after position change	After genearal anesthetic induction, arterial blood gas analyssis (ABGA)was done at supine position. And then the position was changed to prone. 5minutes after prone position change, ABGA repeated, and calculated the dead space ventilation at each point.; Dead space ventilation (Vd/Vt) = [PaCo2-PETCO2]/PaCo2; Finally, we would compare changes of dead space ventilation after position change.	5 minute after prone position
Secondary	Hemodynamic change	Check the hemodynamic changes according to PEEP change : 0,3,6 and 9 cmH2O	1min after PEEP change